Phase IV comparative, randomized, open-label pilot study to evaluate the efficacy and safety of a rilpivirine-based antiretroviral treatment regimen in HIV-infected patients with metabolic liver disease who maintain undetectable HIV viral load

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503110-23-00

Acronym

GESIDA 12422

Enrollment

Registered

2023-03-29

Start date

2023-05-05

Completion date

2025-07-07

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic liver disease in HIV-infected people

Brief summary

no progression and/or regression of liver fibrosis measured by non-invasive tests at month 18, measured as: 1. No change in liver stiffness measured by TE or FIB4 at the 18-month visit from baseline in the intervention group (arms 1 and 2) versus the control group. 2. Reduction in liver stiffness as measured by TE or FIB4 at the 18-month visit from baseline in the intervention group (arms 1 and 2) versus the control group.

Interventions

DRUGJuluca 50 mg/25 mg film-coated tablets

DRUGEmtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg filmdragerade tabletter

DRUGTruvada 200 mg/245 mg film-coated tablets

DRUGDescovy 200 mg/25 mg film-coated tablets

DRUGEviplera 200 mg/25 mg/245 mg film-coated tablets

DRUGTivicay 50 mg film-coated tablets

DRUGEmtricitabina/Tenofovir disoproxilo Aurovitas 200 mg/245 mg comprimidos recubiertos con película EFG

DRUGOdefsey 200 mg/25 mg/25 mg film-coated tablets

DRUGEDURANT 25 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
no progression and/or regression of liver fibrosis measured by non-invasive tests at month 18, measured as: 1. No change in liver stiffness measured by TE or FIB4 at the 18-month visit from baseline in the intervention group (arms 1 and 2) versus the control group. 2. Reduction in liver stiffness as measured by TE or FIB4 at the 18-month visit from baseline in the intervention group (arms 1 and 2) versus the control group.	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026